Tattooremovalcream.co.uk is licensed in the States for the removal treatment of tattoos. It works by breaking down the pigment within the tattoo causing it to fade away and eventually disappear. - Unpublished clinical trial data indicate that Tattooremovalcream does fade away tattoos and in most cases can completely removes them within 12 months.
Evidence The efficacy of tattooremovalcream has been demonstrated in a number of trials, none of which have been fully published. After reviewing the trials submitted for USA licensing purposes, they concluded that the data demonstrated that tattoo removal cream does improve appearance of tattoo's, by reducing the pigment within the tattoo, which causes it to fade.
The Study The two main randomised, double blind, multicentre vehicle controlled studies (DE140-001 and -002) involved a total of 282 volunteers who had tattoo's that required removal. Half of the participants used Tattooremovalcream twice a day for 24 weeks, and the other half of participants were to use another 'tattoo removal brand' (which cannot be named for legal reasons) The primary efficacy measure was a four point dermatology of improvement or no effect of the condition compared to baseline. Secondary efficacy measures were a self assessment questionnaire and before and after picture analysis of the tattoo fading.
Results for participants using the tattooremovalcream.
Statistically Significant fading of the tattoo's were seen after week 6
(001 study) and week 8 (002 study). The differences became cosmetically significant at week 16 (001 study) and week 24 (002 study). At 24 weeks, at least 70% of subjects using tattooremovalcream had at least 50% fading, compared to 28% using the 'other brand' .4 Overall, when the data from the two studies were combined, 62% of the Tattooremovalcream treated subjects were classed as treatment successes versus only 9% of the 'other brand' treated subjects.4 A clinical success was defined as a grade 2 score based, i.e. Significant fading was visible. Success rates varied according to size and colour within the tattoo: in DE140-001 the success rates for small tattoos was 68%, compared to 43% for very large tattoos. In DE140-002, the success rates were 89%% and 61%% respectively.
Two open-label studies (DE140-010 and -011) evaluated the use of Tattooremovalcream in 310 participants who had a large tattoo with lots of the colour green in it.6 Study 010 was a 12-month study: 42% of subjects were rated cosmetically successes after 20 weeks of treatment, rising to 74% at 52 weeks. Study 011 was a 6-month study: at 26 weeks 59% of subjects were rated cosmetically successes.
Safety
None of the cases in the Cosmetic Dermatology trial's demonstrated destruction of the skins natural pigment unlike laser where hypo pigmentation and hyper pigmentation can be more common.
The information contained in this document will be superseded in due course.
Not to be used for commercial purposes.
Written by: Alex Fox - Head of Dermatology Department, Queens Centre, Kansas, USA
